You might have noticed that I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly-unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners. Most of this, of course, is no news to SBM readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over two years now. It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog. Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1:

As far as clinical trials go, it was a joke…it was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

And Jaffe’s characterization of the six dozen phase II clinical trials that Burzynski submitted in the late 1990s was this:

A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

I’m just repeating those quotes again, because they can’t be emphasized enough. Quite frankly, if I were Burzynski, I’d fire Jaffe for having published such statements in his book. But that’s just me. In the meantime, let’s take a look at the counterattack and why Burzynski’s excuses regarding the deficiencies found in the FDA reports do not ring true.(more…)

This is an SBM public service announcement—with blogging! Think of it as a bonus post, and don’t forget to read Mark Crislip’s regular biweekly offering, as it’s about an article in Skeptical Inquirer that particularly irritated him—and me, as well. Because, as we all know, the world needs more Mark Crislip.

I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Indeed, just type his name in the search box of this blog, and you will see copious evidence of my disdain for the man. Over 37 years, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made twoastoundingly baddocumentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one at least, was very popular.

For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four-decade-long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled, but patients already on them could continue to receive treatment. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.

Another venerable scientific journal has fallen prey to “alternative” medicine research. The Journal of the American Dental Association (JADA) has joined the New England Journal of Medicine and Annals of Internal Medicine, among others, with its publication of “A pilot study of a chiropractic intervention for management of chronic myofascial temporomandibular disorder,” in the October, 2013, issue.

And what “chiropractic intervention” is this? The Activator Method Chiropractic Technique (AMCT) as taught by Activators Methods International (AMI), which also conveniently sells its own line of Activator Instruments. (Practice-building seminar DVDs sold separately.)

What is this Activator Method? In short, it is a method of detecting and correcting subluxations (the chiropractic version, not the medical one). Thus, the underlying premise of this study was that subluxations could cause myofascial temporomandibular disorder (TMD) pain and that finding and vanquishing these subluxations could bring about pain relief.

Now, as regular readers of this blog know, vertebral subluxations are a figment of the chiropractic imagination. They do not exist, as we have pointed out many, many, many times. And here is where alternative medicine has it all over conventional medicine and dentistry. In alternative medicine, once you invent a non-existent condition you can proceed to invent all sorts of diagnostic techniques and remedies to treat patients with this condition. The AMCT is a perfect example of this. Conventional medicine and dentistry, on the other hand, are saddled with the scientific method, biological plausibility, having to discard therapies when studies no longer support their use, and all sorts of other persnickety limitations.(more…)

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.(more…)

Oh, and consider it a bit of a taste of what’s to come tomorrow…and don’t forget to pay attention to Bob Blaskiewicz’s plea at the end of his talk to contact him if you’re interested in becoming active. At TAM, he had a sign-up sheet that he discussed at around 21:06 in the video. Online, just mosey on over to The Other Burzynski Patient Group and contact Bob Blaskiewicz. We will very likely be asking you to help very soon.

If there’s one medical treatment that proponents of “alternative medicine” love to hate, it’s chemotherapy. Rants against “poisoning” are a regular staple on “alternative health” websites, usually coupled with insinuations or outright accusations that the only reason oncologists administer chemotherapy is because of the “cancer industrial complex” in which big pharma profits massively from selling chemotherapeutic agents and oncologists and hospitals profit massively from administering them. Indeed, I’ve lost track of the number of such rants I’ve deconstructed over the years. Usually, they boil down to two claims: (1) that chemotherapy doesn’t work against cancer (or, as I’ve called it before, the “2% gambit“) and (2) that the only reason it’s given is because doctors are brainwashed in medical school or because of the profit motive or, of course, because of a combination of the two. Of course, the 2% gambit is based on a fallacious cherry picking of data and confusing primary versus adjuvant chemotherapy, and chemotherapy does actually work rather well for many malignancies, but none of this stops the flow of misinformation.

Misinformation and demonization aside, it is also important to realize that the term “chemotherapy,” which was originally coined by German chemist Paul Ehrlich, was originally intended to mean the use of chemicals to treat disease. By this definition, virtually any drug is “chemotherapy,” including antibiotics. Indeed, one could argue that by this expansive definition, even the herbal remedies that some alternative medicine practitioners like to use to treat cancer would be chemotherapy for the simple reason that they contain chemicals and are being used to treat disease. Granted, the expansive definition evolved over the years, and these days the term “chemotherapy” is rarely used to describe anything other than the cytotoxic chemotherapy of cancer that in the popular mind causes so many horrific side effects. But in reality virtually any drug used to treat cancer is chemotherapy, which is why I like to point out to fans of Stanislaw Burzynski that his antineoplastons, if they actually worked against cancer, would be rightly considered chemotherapy, every bit as much as cyclophosphamide, 5-fluorouracil, and other common chemotherapeutics.(more…)

Science-Based Medicine authors tend to focus attention on practices that misuse or ignore the tools of science. This is not a criticism. As a daily reader and occasional contributor, I recognize that shining a light on pseudoscience is a critical part SBM’s mission. It is what brings me back day after day. Sometimes, however, it is nice to highlight what real science and real evidence can do.

In my world of treating patients with retinal disease, a revolution has taken place over the past few years. The most aggressive form of macular degeneration has been transformed from a relentlessly progressive, disabling disease to one which can be tamed with medication. Now, patients diagnosed with exudative macular degeneration can expect stabilization and even improvement in vision.

It is a story worthy of a Hollywood movie. Start with a reluctant hero; add controversy, Wall Street, politics, and most important of all, a happy ending.(more…)

First, my bias. I work in Portland and we have medical students, residents, and faculty who are DOs (Doctor of Osteopathy). Before he moved on to be a hospitalist my primary physician was a DO. From my experience there is no difference between an MD and a DO. In my world they are interchangeable. There are many more qualified applicants for medical education than positions in MD programs and some opt for a DO education. Osteopathy has a dark side.
As best I can determine from my colleagues, learning osteopathic manipulation (OM) is the price they pay to obtain an otherwise standard medical education. I have yet to see OM offered by any of my DO colleagues. It may be they know better than to offer such a modality around me given my ranty propensity for all things SCAM.

The literature would suggest that OM is left behind by most DOs upon graduation. DOs are not proud of their OM, and rarely invite them ‘round to dinner. It will be interesting to see if OM fades over time in DO school as the old time true believers die off and are supplanted by a generation of DOs trained with more traditional medical education.

OM, the small pseudoscientific aspect of DO medical school education, is a form of massage and manipulation invented in the 19th century with no basis in reality. OM postulates

the existence of a myofascial continuity – a tissue layer that interlinks all parts of the body. By manipulating the bones and muscles of a patient a practitioner is supposed to be able to diagnose and treat and variety of systemic human ailments.

Studies into the efficacy of OM find it to be ineffective for any process aside from low back pain (is there anything that does not help low back pain?), not surprising for a therapeutic intervention detached from reality. My purpose with this entry is not to review OM per se, which may be a good topic someday, but to focus on a specific application of OM. (more…)

Tomorrow, as mandated by the Patient Protection and the Affordable Care Act (PPACA, often called just the Affordable Care Act, or ACA, or “Obamacare”), the government-maintained health insurance exchanges will open for business (that is, assuming the likely government shutdown doesn’t stop them temporarily). We here at SBM have written about the ACA quite a few times, but I would like to write about it in perhaps an entirely different context than you’re used to now that the biggest change mandated by the law is here. Just to see the contrast, I’ll mention that Jann Bellamy has written about the ACA in the context of how provisions have been inserted by promoters of “complementary and alternative medicine” (CAM) could potentially provide an “in” for requiring reimbursement of CAM practitioners for their services by insurance plans sold through the exchanges or even how CAM practitioners might promote themselves as primary care providers (PCPs) under Obamacare, as did Matt Roman. I myself warned about legislative meddling that might permit funding of religion-based health care in the exchanges, and Kimball Atwood sounded early warnings about insertion of the provisions that Jann warned about. Instead, view this discussion as a follow-up to a post I did almost a year ago that used a statement by Mitt Romney during the height of the Presidential campaign as a jumping off point to look at the relationship between health insurance status and mortality. While we at SBM try to remain more or less apolitical, in some cases (licensing of naturopaths, for example) it is not possible to disentangle science from politics, and we have to dive in. Also, politics is the art of the possible; so, policy-wise, what is best as determined by science might well not be what is possible politically.

The reason I wanted to revisit this topic is because of a political battle that went on for quite some time over the last several months to expand Medicaid in Michigan according to the dictates of the ACA. The reason that this battle is occurring in many states is because when the Supreme Court ruled last year that the individual mandate requiring that citizens have health insurance was Constitutional, one provision that it ruled unconstitutional was the mandatory expansion of Medicaid in states participating in the Medicaid program to cover all people under 65 up to 133% of the federal poverty level. States thus had to decide whether or not they would accept the Medicaid expansion. In our state, Governor Rick Snyder supported the expansion. Even though he is Republican, he is also a businessman and realized that it was a good deal, with the federal government covering 100% of the cost for the first three years and then phase down to 90% of the cost in 2020. The bill to expand Medicaid managed to pass the House of Representatives, but then it stalled in the Senate. Unfortunately—and this is what got me involved—my state Senator Patrick Colbeck led the opposition to the Medicaid expansion in the Senate, much to my chagrin and disappointment. His argument, which is being repeated elsewhere in the blogosphere, is that Medicaid is worthless and doesn’t improve health outcomes. Instead, he endorsed an alternative that (or so he claimed) places Medicaid-eligible patients into in essence low cost, high deductible concierge practices, with health savings accounts. This was a plan promoted by practices like BlueSky Health. Ultimately Mr. Colbeck lost, and Medicaid was expanded in Michigan in a plan that was characterized by John Z. Ayanian in this week’s New England Journal of Medicine as “a pragmatic pathway to link Republican and Democratic priorities for health care.”

However, the whole kerfuffle got me to thinking. In my post a year ago, I basically asked what the evidence was that access to health insurance improves health outcomes, but I didn’t really stratify the question into kinds of health insurance. Rather, I just looked at being uninsured versus having health insurance. After my little Facebook encounter with one of my elected representatives, I wondered what, exactly, was the state of evidence. So I decided to do this post. In the U.S., currently we have in essence three kinds of health insurance, broadly speaking: private insurance, Medicare, and Medicaid. Medicare, for those of our readers from other countries, is a plan that covers the medical care of people 65 and over and those receiving Social Security disability benefits. It is funded through payroll taxes and directly paid for by the federal government. Medicaid, in contrast, is a plan designed for low income people who fall below certain income levels. Also in contrast, it is jointly funded by the states and the federal government with each participating state administering the plan and having wide leeway to decide eligibility requirements within the limits of federal regulations that determine the minimal standards necessary for states to receive matching funds. Indeed, the loss of this leeway to determine the income level at which a person is eligible for Medicaid is one of the reasons the provision for Medicaid expansion was part of the Supreme Court challenge to the ACA. These days, most Medicaid plans hire private health maintenance organizations (HMOs) to provide insurance. Finally, what needs to be understood is that, compared to private insurance, Medicare reimbursement rates tend to be lower and Medicaid reimbursement rates are lower still, which is part of the reason why a lot of doctors don’t accept Medicaid. Increases in reimbursement under the ACA might well help this situation. (more…)

It’s likely you know someone who has bought into the notion that nutrition is everything, the source of all health and the cause of all illness. Nutrition is very important, to be sure, but it is only one of many possible causes of disease, and if you live in a Western industrialized nation you probably have adequate nutrition. The notion, however, that food can heal is powerfully alluring, and it makes great headlines. The result is that people who read the headlines for the latest food to avoid, or the latest ingredient that will make them live longer or stave off disease, seem to have an association for everything. Eating around them is to be constantly told that food X is good for you and will prevent Y, or that some other food should be avoided because it causes Z.

My usual response when offered such advice is – you know, food is healthy for you. I recommend you eat food every day. Food is full of nutrition, essential vitamins and minerals, and will give you energy. If you don’t eat food, your health with dramatically suffer. But don’t eat too much food – that’s not healthful.